Fengmei Lian1, Lie Wu1, Jiaxing Tian1, Ming Jin2, Shuiping Zhou3, Min Zhao3, Lijuan Wei4, Yanlin Zheng5, Yuliang Wang6, Mingchang Zhang7, Wei Qin8, Zhifeng Wu9, Chun-Su Yuan10, Xiaolin Tong11. 1. Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China. 2. China-Japan Friendship Hospital, Beijing 100029, China. 3. Tasly Pharmaceutical Co., Tianjin 300410, China. 4. The Affiliated Hospital to Changchun University of Chinese Medicine, Changchun 130021, China. 5. The Affiliated Hospital to Chengdu University of Chinese Medicine, Chengdu 610032, China. 6. Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing 210005, China. 7. The Affiliated Union Hospital to Tongji Medical College of Huazhong University of Science and Technology, Wuhan 430022, China. 8. First Affiliated Hospital of Third Military Medical University, Chongqing 400038, China. 9. Wuxi Number 2 People׳s Hospital, Wuxi 214002, China. 10. Tang Center for Herbal Medicine Research, Pritzker School of Medicine, University of Chicago, IL 60037, USA. Electronic address: cyuan@dacc.uchicago.edu. 11. Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China. Electronic address: xiaolintong66@sina.com.
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE: Salvia miltiorrhiza (Danshen in Chinese) is a common traditional Chinese herbal medicine often used to treat many medical conditions. The Compound Danshen Dripping Pill (CDDP) is a danshen-containing Chinese herbal product for the treatment of cardiovascular diseases. However, to date, no controlled clinical studies have been conducted to evaluate the effects of CDDP on diabetic retinopathy (DR). AIM OF THE STUDY: The present large-scale clinical trial was designed to assess the effectiveness and safety of CDDP in treating patients with non-proliferative diabetic retinopathy (NPDR). MATERIALS AND METHODS:223 NPDR patients were enrolled in this controlled trial. Subjects received oral study medications three times daily for 24 weeks. The four groups were placebo, low-dose (270 mg), mid-dose (540 mg) and high dose (810 mg herbal medicine). Primary endpoints were changes in fluorescence fundus angiography (FFA) and fundoscopic examination parameters. RESULTS AND DISCUSSION: At 24 weeks, for the FFA, the percent of "Excellent" and "Effective" in the high-dose and mid-dose CDDP groups was 74% and 77%, respectively, very significantly higher than 28% in the placebo group (P<0.001). For fundoscopic examination, the percent of "Excellent" and "Effective" in the high-dose and mid-dose CDDP groups was 42% and 59%, respectively, very significantly higher than 11% in the placebo group (P<0.001). No adverse events with clinical significance were observed. CONCLUSIONS: DR is a severe microvascular complication of diabetes and a major cause of adult blindness worldwide. Our clinical trial data demonstrated the therapeutic value and safety of a danshen-containing Chinese herbal medicine in patients with diabetic retinopathy.
RCT Entities:
ETHNOPHARMACOLOGICAL RELEVANCE: Salvia miltiorrhiza (Danshen in Chinese) is a common traditional Chinese herbal medicine often used to treat many medical conditions. The Compound Danshen Dripping Pill (CDDP) is a danshen-containing Chinese herbal product for the treatment of cardiovascular diseases. However, to date, no controlled clinical studies have been conducted to evaluate the effects of CDDP on diabetic retinopathy (DR). AIM OF THE STUDY: The present large-scale clinical trial was designed to assess the effectiveness and safety of CDDP in treating patients with non-proliferative diabetic retinopathy (NPDR). MATERIALS AND METHODS: 223 NPDR patients were enrolled in this controlled trial. Subjects received oral study medications three times daily for 24 weeks. The four groups were placebo, low-dose (270 mg), mid-dose (540 mg) and high dose (810 mg herbal medicine). Primary endpoints were changes in fluorescence fundus angiography (FFA) and fundoscopic examination parameters. RESULTS AND DISCUSSION: At 24 weeks, for the FFA, the percent of "Excellent" and "Effective" in the high-dose and mid-dose CDDP groups was 74% and 77%, respectively, very significantly higher than 28% in the placebo group (P<0.001). For fundoscopic examination, the percent of "Excellent" and "Effective" in the high-dose and mid-dose CDDP groups was 42% and 59%, respectively, very significantly higher than 11% in the placebo group (P<0.001). No adverse events with clinical significance were observed. CONCLUSIONS: DR is a severe microvascular complication of diabetes and a major cause of adult blindness worldwide. Our clinical trial data demonstrated the therapeutic value and safety of a danshen-containing Chinese herbal medicine in patients with diabetic retinopathy.
Authors: Dan Luo; Yali Qin; Wei Yuan; Hui Deng; Youhua Zhang; Ming Jin Journal: Evid Based Complement Alternat Med Date: 2015-09-20 Impact factor: 2.629